drugset / Trial / NCT03164655
Improving SUrgery of Liver Metastases: a Trial of the Arterial Chemotherapy Network
RandomizedParallel-groupDouble-blindTreatment
Summary
National trial, multicenter, randomized, phase II comparing treatment intensification with hepatic arterial infusion chemotherapy plus systemic chemotherapy (CT) to systemic chemotherapy alone in patients with liver-only colorectal metastases (CRLM) considered still non resectable after at least two months of systemic induction chemotherapy.
Timeline
- Start
- 2018-07-25
- Primary completion
- 2021-07-15
- Completion
- 2021-11-15
Outcome
Missed primary endpoint
paper our study could not confirm that salvage HAI combined with sys-CT improved CTR and survival outcomes compared with Sys-CT alone. PMID 41118066 ↗
Publications
- Boileve A, Audemar F, Dupont-Bierre E, Le Sourd S, Ulusakarya A, Chauvenet M, Benmaziame A, Wagner M, Goere D, Dromain C, Gelli M, Pezzella V, Bonnet B, Tanguy ML, Boige V. Treatment Intensification with Hepatic Arterial Infusion Chemotherapy in Patients with Liver-Only Colorectal Metastases Still Unresectable After Systemic Induction Chemotherapy: Exploratory Findings From a Prematurely Closed Multicenter Randomized Phase II Study: SULTAN UCGI 30/PRODIGE 53 (NCT03164655). Ann Surg Oncol. 2026 Feb;33(2):1460-1469. doi: 10.1245/s10434-025-18570-5. Epub 2025 Oct 21.
- Boileve A, Maillard A, Wagner M, Dromain C, Laurent C, Dupont Bierre E, Le Sourd S, Audemar F, Ulusakarya A, Guerin-Meyer V, Smisth D, Pezzella V, De Baere T, Goere D, Gelli M, Taieb J, Boige V. Treatment intensification with hepatic arterial infusion chemotherapy in patients with liver-only colorectal metastases still unresectable after systemic induction chemotherapy - a randomized phase II study -- SULTAN UCGI 30/PRODIGE 53 (NCT03164655)- study protocol. BMC Cancer. 2020 Jan 30;20(1):74. doi: 10.1186/s12885-020-6571-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | Other |
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | Cetuximab | Monoclonal antibody | 500 mg/m2 | Intravenous |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Panitumumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |